A research agenda to improve incidence and outcomes of assisted vaginal birth

Abstract Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women’s representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women’s perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women’s feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.


Introduction
Assisted vaginal birth, also known as instrumental or operative vaginal birth, refers to a vaginal birth conducted with the help of an instrument such as forceps or a vacuum extractor. 1][7][8] Assisted vaginal birth is not without risks, particularly if conducted inappropriately or by unskilled providers. 9,10ompared with non-instrumental vaginal birth, the use of forceps is associated with an increased risk of perineal trauma, maternal pain and fetal facial injury; the use of a vacuum extractor is associated with a higher risk of cephalohematoma and failure resulting in caesarean section. 1,11However, these comparisons can be misleading, since a woman in need of forceps or a vacuum extractor is experiencing a second-stage complication or emergency that needs to be addressed: a noninstrumental vaginal birth is no longer an option. 9Because as-Bull World Health Organ 2023;101:723-729| doi: http://dx.doi.org/10.2471/BLT.23.290140   Improving outcomes of assisted vaginal birth Ana Pilar Betrán, et al.
sisted vaginal birth can reduce maternal and perinatal mortality and morbidity, including obstetric fistula, perinatal hypoxia, infection and postpartum haemorrhage associated with prolonged labour, the World Health Organization (WHO) recognizes it as an integral part of basic emergency obstetric care. 1,7,9,12,13,15 The alternative to assisted vaginal birth for women who have secondstage complications is a caesarean birth.However, compared with a pre-labour or first-stage caesarean birth (i.e. when the cervix is not fully dilated), a caesarean delivery performed during the second stage of labour presents additional risks, including major haemorrhage, infection, extension of the uterine incision and trauma to the baby's head. 16For many women, an assisted vaginal birth can therefore be safer than an emergency second-stage caesarean birth. 7,9,13,17,18][21][22] The cost-effectiveness of these interventions has not been extensively studied.However, in the United States of America, a cost-effectiveness model analysis of neonatal and maternal outcomes of assisted vaginal birth versus caesarean birth was conducted. 23This study suggested that assisted vaginal birth was more cost-effective, with analyses indicating higher quality-adjusted life years of the mother and neonate as well as reduced costs.

Declining practice
5][26] In the last three decades, the proportion of all births by caesarean section has increased from a global average of about 6% in 1990 to 21% in 2018. 25,27][30] Despite the fact that caesarean births entail greater risks in low-and middleincome countries -a result of the poorer quality of services and reduced access to comprehensive obstetric care in the case of complications -assisted vaginal births comprise less than 1% of all births in such settings. 5,26,31,32Increased access to the practice of assisted vaginal birth can support efforts towards reducing the use of second-stage caesarean birth and its associated short-and long-term risks.
Multiple factors contribute to the underuse of assisted vaginal birth globally: the practice requires clinical judgement, expertise and skills, but there exists a lack of adequately trained health-care providers, not only to conduct the procedure but also to identify which labouring women could benefit. 26,33,346][37] The lack of functioning, reliable and affordable equipment at the point-of-care is also a limiting factor to sustainability, 1,26,34 as is the lack of or suboptimal pain relief. 389][40] Because it is widely perceived as safer and more modern than vaginal birth, and a way to guarantee the best outcome for mother and child, caesarean birth is becoming a social norm among women and their relatives. 40,41ull World Health Organ 2023;101:723-729| doi: http://dx.doi.org/10.2471/BLT.23.290140   Improving outcomes of assisted vaginal birth Ana Pilar Betrán, et al.

Three-step process
WHO recognizes the crucial role of assisted vaginal birth in improving maternal and perinatal outcomes, but also acknowledges the need to conduct research to identify and address barriers to its implementation.WHO therefore led a three-step process to foster thinking and catalyse research on how to optimize the use of assisted vaginal birth, especially in low-and middleincome countries: (i) evidence syntheses; (ii) technical consultation with experts; and (iii) gathering of feedback and views from women's representatives.We combined the results and outcomes from all three steps to identify the areas in which research, political engagement and support, and resources are urgently required.

Evidence syntheses
First, we conducted one quantitative and two mixed-methods systematic reviews of the global literature describing research on barriers to, and factors facilitating the use of, assisted vaginal birth.Our quantitative review synthesized evidence from 16 studies (10 based in low-and middle-income countries) that implemented interventions to increase or reintroduce the use of assisted vaginal births, including didactic sessions, simulation, handson training, guideline production and audit/feedback. 37Our mixed-methods reviews aimed to improve our understanding of (i) experiences and facilitators of, as well as barriers to, assisted vaginal birth (42 studies); 38 and (ii) competencies and expertise required, as well as barriers to and facilitators of, such competencies and expertise, from the point of view of health-care professionals (27 studies). 34

Consultation with technical experts
This synthesis of evidence informed a consultation with 37 technical experts, including health-care providers, researchers, policy-makers and public health experts selected for their wide range of experience, perspectives and geographical locations.A research agenda required for the safe reintroduction of, or increased access to and use of, assisted vaginal birth, especially in low-and middle-income countries, was tentatively identified by participants of the consultation.

Women's views
Following the experts' initial identification of a research agenda, we ascertained the perceived importance and relevance of this agenda at four workshops to which representatives of women's and advocacy groups from 27 different countries were invited.To accommodate the range of languages spoken and geographical locations, the workshops were conducted online (each lasting 1.5-2 hours) in English (two), French (one) and Spanish (one) during April-May 2022.Each workshop was conducted by two independent professional facilitators contracted to WHO.Around a week before each workshop, participants were sent the tentatively identified research agenda so that they could begin to consider and construct their views on each research topic.The facilitators led discussions during the workshops and noted the opinions expressed; the facilitators then prepared reports detailing the women's views on the importance and relevance of the topics on the identified research agenda.

Research agenda
Earlier in 2023, WHO published a technical brief describing the results of this process; please see this technical brief for a tabulated form of the following. 42We categorized the topics within the identified research agenda as: (i) women's perception of assisted vaginal birth; (ii) training of health-care providers and clinical aspects; and (iii) implementation and sustainability of the practice.The key messages and implications of the process and outcomes in each of the three categories are discussed below, and include the views and perspectives developed by both the technical consultants and women's representatives.

Perception
Accessing reliable information and debunking misconceptions about assisted vaginal birth may be a challenge in contemporary societies.Although most women have basic information about a caesarean birth, many are less familiar with assisted vaginal birth.The views of those who are aware of the practice may have been affected by catastrophic but rare outcomes, undermining evidencebased information and reliable statistics.
WHO therefore emphasizes the need for research to understand how assisted vaginal birth is perceived by women and communities, and also how to provide appropriate, reliable and unbiased information about the practice.Determining the most effective ways to communicate information to women and their communities across different settings (e.g.low levels of literacy, poor internet availability, marginalized or minority populations) is crucial.The provision of decision-making tools for women as well as the role of various communication channels (e.g.social media) should both be explored.
Women emphasized the importance of recognizing childbirth as a physiological process, as opposed to an illness.Recurrent concerns about assisted vaginal birth reported at the workshops were the safety of the practice, and the consequences of adverse events on both the newborn and mother.Women were greatly troubled by an apparent lack of follow-up and support (e.g.expressed in concerns about overburdened health systems and a lack of infrastructure and equipment) in the case of complications.Finally, the misuse of informed consent and its consequences (e.g.fear, disempowerment and abuse) was identified as a source of distress for women.

Training and clinical aspects
The importance of well-trained, skilled, knowledgeable and competent healthcare providers cannot be overemphasized.Research is needed to identify the most effective ways to educate and train health-care providers to not only perform assisted vaginal birth, but also to recognize the indications and conditions for its safe use, the contraindications and how to manage any complications.The latter is particularly crucial since fear of complications is a documented deterrent for health-care providers considering offering assisted vaginal birth.In addition to improving the clinical skills of providers, training should include other skills such as effective communication, situation awareness, shared decision-making, informed consent, and how to respectfully guide women and their birth companions and/or family through the birth experience.
Subsequently To be able to address recurrent concerns about the safety of the practice, studies comparing the effect of assisted vaginal birth with secondstage caesarean birth on both the short-and long-term maternal (e.g. the effect on the pelvic floor) and newborn outcomes are needed.In terms of clinical practice, research is needed on the optimal analgesia methods for assisted vaginal birth across different settings, and on the safety, feasibility and effectiveness of new technologies to perform the practice such as the OdonAssist device. 1,43,44Development of technologies that are simple, userfriendly and reusable may have the most impact.
The labour and birth environment (e.g.maternity structures, resources, support and organizational ethos) has the potential to represent either an insurmountable barrier or an important ally in access to high-quality care for pregnant women.It is therefore important to investigate (i) the factors that incentivize caesarean births and foster inequalities in access to assisted vaginal birth; and (ii) the changes required in the culture of obstetric health-care institutions and systems to prevent disrespect, abuse or overmedicalization.

Implementation and sustainability
To implement and sustain the practice of assisted vaginal birth, particularly in settings where second-stage caesarean birth may be a riskier option, research is needed to assess maternity organizational models for effective access.Because midwives are the main providers of health care in rural and remote areas of many low-and middle-income countries, assessing the safety, feasibility and effectiveness of midwife-led models of care; exploring the role of midwives, as well as investigating how to train and empower them to undertake assisted vaginal birth safely and effectively, is fundamental.Regardless of the organizational model, ensuring timely access to emergency caesarean section if assisted vaginal birth fails is also crucial.Health-care providers need a supportive work environment, including relevant training, mentoring by more experienced colleagues, and close supervision until an appropriate level of confidence and competence is reached.
Other questions that need to be answered include how to manage political and financial barriers, including the structure of the insurance system.Change will be difficult as long as a caesarean birth is more profitable for the system. 45It is important to ensure that funding is available to acquire and maintain essential equipment, and to determine which interventions other than education (e.g.audit and feedback, opinion leaders) could be effective in changing obstetric practices that are acceptable to both women and health-care providers.Studies demonstrating the cost-effectiveness of the increasing use of assisted vaginal birth are crucial for the engagement of governments, policymakers and professional associations.
In current obstetrics, the challenge of increasing the use of assisted vaginal birth is complex because of the interconnected multiple players (e.g.women, health-care providers, policy-makers and professional associations); accepted cultural norms; the dynamic healthcare environment; and the numerous behavioural factors (e.g.fear of pain, a poor outcome, or disrespect during labour) that influence decision-making for mode of birth. 45Such complexity requires operational implementation research, using a systems-thinking approach with its toolbox of motivation changers (e.g.accountability, peer pressure, champions, emerging leadership). 46e systematic use of behavioural science is also warranted to address all barriers and concerns while harnessing the factors facilitating appropriate use. 47,48

Conclusion
Access to assisted vaginal birth is an integral part of emergency obstetric care; we have therefore identified a research agenda to counter the significant decline in its use.Women's representatives generally agreed with the research agenda initially identified by the technical experts, but also stressed the importance of engaging women and health-care professionals at all stages of this research.Women also emphasized the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if and when needed.The promotion and/ or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.Shared and informed decision-making and constructive communication are considered crucial for reducing apprehension and building trust between women and health-care providers.■ Bull World Health Organ 2023;101:723-729| doi: http://dx.doi.org/10.2471/BLT.23.290140   Improving outcomes of assisted vaginal birth Ana Pilar Betrán, et al.
, it is essential to develop comprehensive guidelines and training packages that can be used and adapted at country level.As country-level opinion leaders, national professional associations must play an Bull World Health Organ 2023;101:723-729| doi: http://dx.doi.org/10.2471/BLT.23.290140Improving outcomes of assisted vaginal birth Ana Pilar Betrán, et al.